Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Table C.1 Chronological Summary of Critical Events, NHF Communications,
Critical Event
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
July 16, 1982: CDC MMWR reports immunesuppressive disorder identified in three hemophiliac patients
July 14, 1982: Patient Alert #1 sent to NHF chapters and treatment centers
Speculation that it may be transmitted similarly to hepatitis virus by blood and blood products
Risk is minimal
No change in treatment
Dr. Aledort, NHF medical co-director to serve on PHS task force
Surveillance and reporting system being planned by CDC with NHF cooperation
''Dear Colleague" letter sent (July 19, 1982) to physicians by Dr. Aledort asking them to report any cases to state health departments and the NHF
July 16, 1982: FDA Office of Biologics holds information exchange meeting on the three cases with NHF and CDC representatives
July 19, 1982: Chapter Advisory #2 issued
Cause of disease unknown
No indication blood products are involved
No change in treatment (refers to this as a CDC recommendation)
Epidemic known by CDC in some homosexuals and recent Haitian immigrants
Risk is minimal
CDC investigating: (1) linkage between hemophiliacs and other populations; (2) whether the disease may be a virus transmitted similarly to hepatitis by blood products

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
July 27, 1982: PHS meeting on opportunistic infections in hemophiliacs
July 30, 1982: NHF issues Medical Bulletin #2 and Chapter Advisory #3 (no mass mailings to chapter members required)
The cause of the dysfunction found in three hemophiliacs is unknown, now defined as AIDS
No information provided
No information provided
NHF agrees to work with CDC, FDA, and NIH to establish surveillance system of hemophiliacs with symptoms of opportunistic infections

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Critical Event
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
December 10, 1982: CDC MMWR reports four additional cases in hemophiliacs and one suspect case in an infant who had received a blood transfusion
December 9, 1982: NHF issues Chapter Advisory #4
Two cases are children with hemophilia
Illness may pose a significant risk for hemophiliacs
Advisable not to introduce concentrates to patients who have never used them before (e.g., newborns, children under age 4, newly diagnosed cases, and mild hemophiliac cases)
NHF sends out December 10 CDC MMWR to chapter members and emphasizes that patients and parents should be aware of potential risks
December 10, 1982: Medical Bulletin #3 issued
Not acquired from contact with each other or other high-risk groups
Increased concern that AIDS may be transmitted through blood products
December 21, 1982: NHF issues Medical Bulletin #4 and Chapter Advisory #5
All cases exposed to Factor VIII, no common lots found
No change in treatment for those who have received factor concentrates, and one should not withhold the use of clotting factor therapy when needed
NHF provides treatment alternatives to chapter members for individuals not previously exposed to concentrate
No conclusive evidence that cryoprecipitate or fresh frozen plasma will reduce the risk of AIDS
January 4, 1983: CDC meeting in Atlanta to review data
January 17, 1983: NHF issues Medical Bulletin #5 and Chapter Advisory #6
Growing incidence and increasing concern among hemophiliac patients that AIDS may be transmitted through blood products
Cryoprecipitate should be used for newborns and children under age 4
MASAC meeting on January 14, 1983, issues 12 recommendations to prevent AIDS in hemophiliac patients; the clinical options (at left) were recommendations made to physicians
Benefits of using cryoprecipitate therapy vs. factor concentrate for severe hemophilia A are under review

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
DDAVP should be used whenever possible with mild or moderate hemophilia A
Reevaluate all elective surgical procedure

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Critical Event
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
March 4, 1983: PHS issues recommendations to reduce the risk of AIDS
March 9, 1983: NHF issues Medical Bulletin #6 and Chapter Advisory #7
Sexual contact should be avoided with persons known or suspected to have AIDS; multiple sex partners increase the probability of developing AIDS
Physicians should adhere strictly to medical indications for transfusions, and autologous blood transfusions are encouraged
NHF urges Congress to provide additional funding to support AIDS research
NHF issues mental health report to orient those who treat hemophiliacs to the potential impact of AIDS and asks for medical observations, such as: the impact of the AIDS threat (e.g., number of calls from patients); behavioral or emotional problems; evidence of withholding or refusing factor replacement for acute bleeds; and the treatment center's response
May 1983: Hyland Therapeutics recalls lot—a donor was identified who developed AIDS
May 11, 1983: NHF issues Medical Bulletin #7 and Chapter Advisory #8
Risk is low (12 hemophiliacs out of 20,000 developed AIDS)
NHF and NHF AIDS Task Force recommends hemophiliacs maintain use of clotting-factor treatment

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
August 25–26, 1983: Hyland Therapeutics and ARC announce recall of lots (two each) from identified donors who were confirmed to have died of AIDS
September 7, 1983: NHF issues Chapter Advisory #9
Not scientifically established that AIDS is transmitted through blood products
NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as prescribed by their physicians
October 31, 1983: Cutter Laboratories announces withdrawal of 13 lots of Factor VIII and 1 lot of Factor IX, all from a donor who recently died of AIDS
November 2, 1983: NHF issues Chapter Advisory #11
Not scientifically established that AIDS is transmitted through blood products
Only a fraction of 1% of all hemophiliacs have contracted AIDS
Despite the concern that may be raised by the recall of plasma products, the NHF reaffirms its recommendation that patients maintain the use of concentrate or cryorecipitate as prescribed by their physicians
No common lots have been identified, thus suggesting the great majority of hemohiliacs are not susceptible to AIDS

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Critical Event
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
December 2, 1983: CDC MMWR update on AIDS in hemophiliac patients; results of treatment center survey show no cases occurred before September 1981; 21 hemophiliacs have been diagnosed with AIDS, additional patients have been reported with AIDS-related symptoms that do not fit the CDC criteria for an AIDS diagnosis
December 2, 1983: NHF issues Medical Bulletin #8 with attached CDC MMWR (December 10); Medical Bulletin #9 and Chapter Advisory #12 issued on December 21, 1983
Etiology remains unknown, epidemiological evidence suggests an infectious disease
MASAC revises January 14, 1983, recommendations to prevent AIDS: adds modification of donor screening language; screen donors for symptoms; expedite the development of processing methods to inactivate viruses potentially present in factor concentrates
Possibility of transmission by blood and blood products is supported by increased incidence of AIDS in IV drug users and transfusion recipients
Cryoprecipitate and factor concentrates are associated with transmission of known viral agents (i.e., cytomegalovirus, hepatitis B, and non-A, non-B hepatitis)
January 16, 1984: Alpha Therapeutic recalls three lots contaminated with AIDS from a donor diagnosed with AIDS
NHF issues Medical Bulletin #10 and Chapter Advisory #13
NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as prescribed by their physicians
MASAC recommends to blood product manufacturers that any lot of concentrate be recalled if it includes material from an individual who has been identified as having AIDS, or from an individual who, in the best judgment of the manufacturers, has characteristics strongly suggestive of AIDS

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
January 1984: Annals of Internal Medicine publishes article on sexual transmission of AIDS
January 30 and February 3, 1984: NHF issues Medical Advisory #11 and Chapter Advisory #14
First case of sexually transmitted AIDS from hemophiliac to spouse: a 70-year-old hemophiliac died of AIDS in May 1983; his wife had developed symptoms in January 1982
In the medical and scientific communities there are different points of view about whether sexual partners of hemophiliacs are at increased risk for AIDS; but all agree that if sexual partners are at increased risk for AIDS, the risk is "truly remote"
Individual patients and their treaters need to consider whether or not they wish to use prophylactic methods if diagnosed with AIDS or strongly suspected of having AIDS; discuss with physician or treatment center team matters concerning sexual activity
NHF recommends open discussion between sexual partners and advice from physicians

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Critical Event
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
April 2, 1984: core testing initiated
April 16, 1984: NHF issues Chapter Advisory #15
January–March 1984:9 new cases of AIDS among hemophiliacs, total now is 33; fluctuations, such as an increase in the number of AIDS cases, are due to the small number base of hemophiliacs; antibody to hepatitis B core protein is found in many of the high-risk groups
DDAVP approved by FDA
April 1984: Lancet publishes Montagnier's isolation of LAV; Science publishes Gallo's isolation of HTLV-III (September 1985)
May 9, 1984: NHF issues Chapter Advisory #16
HTLV-III may cause AIDS; both a test and a vaccine are several years away; genetic production of Factor VIII will reportedly also be available in several years
July 13, 1984: CDC MMWR reported 72% of severe asymptomatic hemophiliac had antibody to LAV antigens using the Western blot test
July 31, 1984: NHF issues Chapter Advisory #17 and Medical Bulletin #12
HTLV-III/LAV implicated as the causative agent for AIDS; too early for scientific information about the relationship between testing positive and having AIDS
Testing positive for HTLV-III/LAV does not suggest a diagnosis of AIDS
No information from NHF; CDC MMWR states that prevention measures should stress that transmission has been only from sexual contact, sharing of contaminated needles, and, less often, from transfusion of blood or blood products

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
August 31, 1984: Alpha Therapeutic recalls four lots of Factor VIII and four lots of Factor IX from an identified donor who was confirmed to have AIDS
September 6, 1984: NHF issues Medical Bulletin #13 and Chapter Advisory #18
NHF reaffirms its recommendation that patients maintain use of concentrate or cryoprecipitate as recommended by their physicians
MASAC reaffirms October 23, 1983, policy on recall

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Critical Even
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
October 5, 1984: ARC recalls AHF found to have been from a single donor who developed AIDS
October 13, 1984: NHF issues Medical Bulletin #15 and Chapter Advisory #20 containing MASAC recommendations concerning AIDS and the treatment of hemophilia
Heat-treated products appear to have no negative impact in terms of inhibitor development from heat treatment
On October 13, 1984, MASAC revises its recommendations: treaters using coagulation factor concentrates should strongly consider changing to heat-treated products
Insufficient data to know with certainty whether heat-treated products should be universally adopted; preliminary evidence suggests that HTLV-III/LAV is heat labile
Reevaluate all elective surgical procedures
Use DDAVP for mild or moderate hemophiliacs
Cryoprecipitate should be used for newborns, children under age 4, and newly diagnosed patients; continue treating bleeding episodes with clotting factor as prescribed by their physicians
Provide patient education and psychosocial support
October 26, 1984: CDC MMWR reports information on the viral inactivation success of heat treatment
November 5, 1984: NHF issues Medical Bulletin #16 and Chapter Advisory #21
MMWR provides scientific evidence on the efficacy of heat treatment
NHF reiterates MASAC recommendation that treaters should strongly consider changing to heat-treated products

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
November 4, 1984: the media reports that 70%–90% of hemophiliacs are infected with AIDS
November 5, 1983: NHF issues Medical Bulletin #17 and Chapter Advisory #22 in response to misleading information
58 Cases of AIDS in hemophiliacs; 32 have died
The presence of antibodies for HTLV-III/LAV does not suggest a diagnosis of AIDS
FDA licenses three manufacturers for heat-treated Factor IX (1984)
December 11, 1984: NHF issues ''sensitive" Medical Bulletin (#19) that includes a list of AIDS cases among hemophiliacs; 58 cases are listed.
Not known whether heat changes effectiveness for patients with inhibitors
Treaters should strongly consider changing to heat-treated products; studies are under way to determine efficacy for hepatitis
December 12, 1984: NHF issues Medical Bulletin #18 and Chapter Advisory #23

OCR for page 247
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Critical Event
NHF Communication
Knowledge Base
Risk Assessment
Clinical Option
NHF Action
October 1984: CDC determines that heat treatment is effective against HIV
December 4, 1985: NHF issues Medical Bulletin #32 and Chapter Advisory #37
MASAC recommends (and the NHF Executive Committee approves) that physicians prescribe only heat-treated products for patients who do not have inhibitors
Heat-treated products should be used for newborns, children under age 4, and newly diagnosed hemophiliacs
Hepatitis B vaccine should be administered shortly after birth because of the problem of non-A, non-B hepatitis (not eliminated with heat treatment) risks and benefits should be weighed for each individual
DDAVP should be used for mild or moderate hemophilia A patients; when it does not work, these patients should be treated with cryoprecipitate; for newborns, children under age 4, and newly identified patients with mild or moderate factor IX deficiency, fresh frozen plasma can be used, but in many circumstances, heat-treated product Factor VIII or IX may be the more appropriate therapy